FDA 510(k) Applications for Medical Device Product Code "GNP"
(Antiserum, Cf, Epstein-Barr Virus)

FDA 510(k) Number Applicant Device Name Decision Date
K981831 DIAMEDIX CORP. IS EBV-EA-D IGG ELISA TEST SYSTEM 02/16/1999
K981829 DIAMEDIX CORP. IS EBV-EBNA-1 IGG ELISA TEST SYSTEM 02/16/1999
K020717 PAN BIO PTY. LTD. EBV V VCA IGM ELISA KIT MODEL# EBM-200 06/13/2002
K020707 PAN BIO PTY. LTD. EBV-EBNA IGG ELISA KIT, MODEL EBG-100 06/13/2002
K020706 PAN BIO PTY. LTD. EBV-VCA IGG ELISA TEST, MODEL EBG-100 06/13/2002


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact